# FDA recall Z-2264-2018

> **TriMed Inc.** · Class II · device recall initiated 2018-04-13.

## Product

Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e) ES-12x15x17; f) ES-12x16x19; g) ES-15x13x16

## Reason for recall

During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly  dose audits/verification required to comply with the regulations could not be found. Sterilization  records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.

## Distribution

U.S.: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL;  OUS: Australia and Sweden

## Key facts

- **Recall number:** Z-2264-2018
- **Recalling firm:** TriMed Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-13
- **Report date:** 2018-06-27
- **Termination date:** 2021-01-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Clarita, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2264-2018

## Citation

> AI Analytics. FDA recall Z-2264-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-2264-2018. Source: US FDA. Licensed CC0.

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